Kornimate/medical-research-clean huggingface dataset:
biohealx® anal fistula device post market surveillance study

Conditions: Fistula-in-ano

Summary: this post market surveillance study is a single arm multicenter study to demonstrate the long-term durability and effectiveness of the biohealx anal fistula device for fistula-in-ano closure (internal and external fistula openings).


Eligibility criteria:
inclusion criteria: * age 18 - 75 years * presence of single continuous anal fistula presenting for initial curative surgery * failed or recurrent anal fistula closure * minimum of 6-weeks of draining seton placed prior to procedure. * availability for follow-up contacts and willingness to complete the informed consent. exclusion criteria: * fistula tract shorter than 2cm * complex fistula tract (branching) * body mass index \> 35 * known uncontrolled diabetes or other systemic condition associated with impaired healing * known hiv-positive or immunocompromised * rectal prolapse * pregnancy * rectal / fistula malignancy * crohn's disease * ulcerative proctitis * hidradenitis suppurativa of the anal region * pilonidal sinus disease * presence of hemorrhoid involving fistula site * continuous use of anti-inflammatory * intersphincteric fistula in ano or fistula treatable by simple fistulotomy * active infection or abscess involving fistula site * known allergy to plga material * any severe acute or uncontrolled chronic disease that according to the investigator might render the patient unsuitable for the study * treatment with an investigational drug or medical device in the past 30 days
ecological momentary assessment and text message intervention for stress management

Conditions: Stress, Psychological; Loneliness; Covid19; Stress

Summary: feasibility and acceptability of an ecological momentary assessment (ema) compared with an ema plus automated text message intervention for stress management

the purpose of this study is to evaluate feasibility and acceptability of an ecological momentary assessment (ema) compared with an ema plus automated text message intervention for stress management in participants with higher-than-average perceived stress conducted in a remote setting. study details include: study duration: 7 months intervention duration: 3 weeks

Eligibility criteria:
inclusion criteria: 1. age 22 years or older 2. must reside in an eastern standard time or central standard time zone 3. able to read and write in english as demonstrated by review and completion of an informed consent form 4. own an sms enabled smartphone 5. scoring \>5 on the 4-item perceived stress scale (reflecting higher-than-average perceived stress) exclusion criteria: 1. reported cognitive impairment and/or psychiatric disorders of the psychotic spectrum 2. enrolled in another support study 3. currently receiving psychotherapy through telehealth 4. phq-9 score of 20 or greater.

Keywords: stress anxiety ecological momentary assessment automated text message intervention
renal blood flow measurement with positron emission tomography (pet)

Conditions: Renal Failure; Renal Artery Stenosis

Summary: two investigational chemical tracers, 62cu-ethylglyoxal bis(thiosemicarbazone) (62cu-ets) and 15o-water, will be used in this study to look at how blood moves through the kidneys. the purpose of the study is to see if 62cu-ets is effective in showing the blood supply to the kidneys compared to 15o-water. the tracer mixes with the blood and moves through the body. using positron emission tomography (pet scan) the researchers can see the tracer and can learn more about how the blood moves through the kidneys. the study invites participants who are healthy, without any heart or kidney disease, patients who have kidney disease that require dialysis, and patients who may have a blockage in one of the arteries supplying blood to the kidneys.


Eligibility criteria:
arm 1. inclusion criteria: * males and females, age 18-40 years * willingness to provide written informed consent exclusion criteria: * history of coronary artery disease (cad) * history of renal disease * risk factors for cardiac disease, renal disease, or atherosclerosis, including diabetes mellitus, hypertension, tobacco abuse, hyperlipidemia, family history of cad or chronic renal failure * history of liver disease or other significant disease * pregnant females arm 2. inclusion criteria: * males and females, age \> 18 years * active hemodialysis or peritoneal dialysis for at least six months * any etiology of chronic renal failure except active glomerular nephritis * presence of two kidneys * willingness to provide written informed consent exclusion criteria: * decompensated heart failure (subjects must be on stable medical therapy for one month) * any previous renal transplant (subjects may be on renal transplant waiting list) * history of liver disease * pregnant females arm 3. inclusion criteria: * males and females, age \> 18 years * documented evidence of renal artery stenosis equivalent to a 75% stenosis by one of the following clinical tests: mra, doppler, renal angiogram, abnormal captopril renal scan * evidence of renal insufficiency with serum creatinine \>= 1.3 mg/dl * presence of two kidneys * willingness to provide written informed consent exclusion criteria: * revascularization of stenotic renal artery * decompensated heart failure (subjects must be on stable medical therapy for one month) * any previous renal transplant (subjects may be on renal transplant waiting list) * history of liver disease * pregnant females

Keywords: renal blood flow pet imaging
phase 2 study of ex-vivo perfusion and ventilation of lungs to assess transplant suitability

Conditions: Emphysema; Chronic Obstructive Pulmonary Disease (COPD); Cystic Fibrosis; Pulmonary Fibrosis; Bronchiectasis; Sarcoidosis; Pulmonary Hypertension; Alpha-1 Antitrypsin Deficiency

Summary: the purpose of this research study is to perfect the technique of evlp and learn about the safety of transplanting lungs that have been ventilated (attached to a breathing machine or ventilator to deliver oxygen) and perfused with a lung perfusion solution (steen solution™, made by vitrolife). this ventilation and perfusion will be done outside the body (ex-vivo) in a modified cardiopulmonary bypass circuit (the kind of device used routinely during most heart surgeries). the purpose of performing ex-vivo lung perfusion and ventilation (evlp) is to learn how well the lungs work, and whether they are likely safe to transplant.


Eligibility criteria:
lung recipient inclusion criteria: * a recipient must meet the following requirement to enroll into the study: * requires a single or bilateral lung transplant and is listed for lung transplant at unc. * male or female, 18 years of age or older. * subject or subject's representative provides a legally effective informed consent. * recipient does not have hiv, active hepatitis or is colonized with burkholderia cepacia. * potential subjects who have undergone previous lung transplants and meet all other inclusion criteria are eligible for study participation. lung recipient exclusion criteria: * recipient fails to meet standard of care requirements for lung transplant, or decides not to participate.

Keywords: lung transplant emphysema chronic obstructive pulmonary disease (copd) cystic fibrosis pulmonary fibrosis bronchiectasis sarcoidosis pulmonary hypertension alpha-1 antitrypsin deficiency
comparison of estrogen and methyltestosterone combination treatments for postmenopausal hot flushes

Conditions: Hot Flushes, Menopause, Postmenopause

Summary: this is a research study to evaluate the effectiveness, safety and side effects of several dose levels of esterified estrogens (ee) and methyltestosterone (mt) given individually and in combination compared to a placebo (a tablet with no active drug in it) as a possible treatment for vasomotor symptoms (such as hot flushes and flushing) of menopause. ee and testosterone are two hormones which are typically deficient in menopausal women


Eligibility criteria:
inclusion criteria: 1. be able to communicate with the investigator and study staff and be able to complete the required study procedures, 2. be a female of any race between the ages of 45-65 years, in generally good health, 3. be either naturally or surgically postmenopausal (with or without a uterus) exclusion criteria: 1. known sensitivity or contraindications to natural or synthetic estrogens, androgens or progestins, 2. history of or current diagnosis of malignant melanoma, breast cancer or any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to beginning the study

Keywords: hormone replacement therapy, hot flushes, postmenopause
predisposing factors for chronic postherniotomy pain

Conditions: Chronic Postherniotomy Pain

Summary: chronic pain affects pain in 5-8% of patients more than a year after groin hernia repair. however no prospective study has investigated potential predisposing factors for development of pain, including genetic, psychosocial and detailed neurophysiological assessment of surgical method. the current study will assess the above factors in a prospective study.


Eligibility criteria:
inclusion criteria: * adult (\>18 years) * male * primary unilateral groin hernia * ability to use pain scales exclusion criteria: * neurological disease * diabetes with late stage complications

Keywords: groin hernia chronic postsurgical pain open mesh repair laparoscopic mesh glue fixation sensory changes after groin hernia repair
cyst fluid glucose for on-site diagnosis of mucinous pancreatic cysts

Conditions: Pancreatic Cyst

Summary: this study evaluates the utility of using cyst fluid glucose levels to diagnose mucinous pancreatic cysts during endoscopic ultrasound-guided fine needle aspiration (eus-fna) procedures.

mucinous pancreatic cysts are considered pre-cancerous. the standard evaluation of pancreatic cysts usually includes endoscopic ultrasound-guided fine needle aspiration (eus-fna). the cyst fluid sample from eus-fna is routinely sent for lab analysis (carcinoembryonic antigen-cea) and cytology assessment. the diagnosis of a mucinous cyst is usually based on those results. for study participants undergoing eus-fna, a small portion of the cyst fluid will be analyzed for glucose levels using a bedside glucometer in addition to the routine analyses. a low cyst fluid glucose level may correlate with a diagnosis of a mucinous cyst. the primary aim of this study will be to determine if a low cyst fluid glucose level correlates with standard laboratory cyst fluid analysis (cea) in establishing a diagnosis of a mucinous pancreatic cyst. secondary aims of this study will be: (1) comparing the accuracy of cyst fluid glucose to cea level among subjects with a proven diagnosis of a mucinous cyst (based on surgery or cytopathology findings), and (2) determining the optimal cyst fluid glucose level that correlates to a proven diagnosis of a mucinous cyst (based on subjects who undergo surgery or have a diagnosis based on cytopathology).

Eligibility criteria:
inclusion criteria: * all adults undergoing standard-of-care eus-fna procedures for the evaluation of pancreatic cysts are eligible to participate * minimum of 1ml of cyst fluid must be aspirated in order to be enrolled in the study exclusion criteria: * inability to perform pancreatic cyst fluid sampling * \<1ml of cyst fluid is aspirated during eus-fna
treatment of chronic renal failure with adipose tissue-derived mesenchymal stem cells

Conditions: Mesenchymal Stem Cells; Chronic Kidney Diseases; Renal Interstitial Fibrosis

Summary: to investigate the biological characteristics of adipose tissue-derived mesenchymal stem cells(amscs) and its treatment effects on chronic renal failure.

this study aims to investigate the biological characteristics of adipose tissue-derived mesenchymal stem cells(amscs) and its effect on oxidative stress, inflammation and mitochondrial damage.we intend to use blood oxygen level-dependent magnetic resonance imaging(bold-mri), emission computed tomography(ect) and enhanced magnetic resonance imaging to monitor renal oxygenation, tissue perfusion and renal function.ultimately, we evaluate the treatment effects of amscs on chronic renal failure through these observations mentioned above.we hope to delay the progression of renal function in patients with chronic renal failure, and save huge social cost for dialysis by these research.

Eligibility criteria:
inclusion criteria: * enroll the chronic renal failure patients without dialysis in the department of nephrology of affiliated hospital of xuzhou medical university from january 2017 to december 2018. * the patients enrolled were not treated with drugs that affect the renal blood flow and oxygen consumption, such as acei, arb, calcium channel blockers, diuretics, vasodilators and other related factors within 2 weeks. exclusion criteria: * exclude those patients with diabetes, cardiovascular disease, severe infection, shock, dehydration, abnormal liver function, received glucocorticoid therapy, surgery and emergency dialysis. * eliminate those patients with respiratory disease(such as chronic obstructive pulmonary disease, bronchiectasis, asthma), cardiovascular diseases(such as acute and chronic cardiac insufficiency), blood system diseases (such as aplastic anemia, nutritional anemia and polycythemia vera).

Keywords: adipose tissue-derived mesenchymal stem cells chronic kidney diseases
study of trazodone & cognitive behavioral therapy to treat insomnia

Conditions: Insomnia

Summary: the purpose of this study is to evaluate the effect of a 3 month medication trial of trazodone versus 3 months of cognitive behavioral therapy (cbt) in patients with chronic insomnia.

participants with chronic insomnia associated with objective short sleep duration will be recruited to participate in a 3 month clinical trial on the efficacy of trazodone versus cbt, with a 6 month follow up. the primary outcome measure will be objective sleep duration as measured by both actigraphy and polysomnography. the secondary outcome measure will be subjective severity of sleep disturbance.

Eligibility criteria:
inclusion criteria: * chronic insomnia with duration of more than 1 year * objective short sleep duration (\< 6 hours) * bmi \< 39 * ages 30-60 * men \& women exclusion criteria: * major mental illness * substance abuse/dependence * sleep apnea * periodic limb movement disorder * shift work or circadian disorders * diabetes * chronic renal failure, hepatic insufficiency, chronic heart failure * current use of hypnotics or sleep inducing sedative antidepressants

Keywords: chronic insomnia short sleep duration trazodone cognitive behavioral therapy efficacy
study of oto-104 in subjects with unilateral meniere's disease

Conditions: Meniere's Disease

Summary: the purpose of this study is to evaluate the effectiveness of oto-104 for the treatment of meniere's disease.


Eligibility criteria:
inclusion criteria includes, but is not limited to: * subject has a diagnosis of unilateral meniere's disease by 1995 american academy of otolaryngology - head and neck surgery (aaohns) criteria and reports active vertigo for the 2 months prior to the study lead-in period. * subject has experienced active vertigo during the lead-in period. * subject has documented asymmetric sensorineural hearing loss. * subject agrees to maintain their current treatments for meniere's disease while on-study. exclusion criteria includes, but is not limited to: * subject is pregnant or lactating. * subject has a history of immunodeficiency disease. * subject has a history of previous endolymphatic sac surgery. * subject has a history of previous use of intratympanic (it) gentamicin in the affected ear. * subject has a history of tympanostomy tubes with evidence of perforation or lack of closure. * subject has experienced an adverse reaction to it injection of steroids. * subject has used an investigational drug or device in the 3 months prior to screening. * subject has previously been randomized to a trial of oto-104.

Keywords: meniere's disease vertigo
perioperative risk factors of outcomes for cardiac surgery: a retrospective study

Conditions: Post-cardiac Surgery; Blood Transfusion Complication; Prognosis

Summary: based on a review of about 10,000 patients undergoing cardiac surgery under cpb in west china hospital of sichuan university and the second affiliated hospital of zhejiang university, we try to evalute the effect of blood transfusion on outcomes in cardiac surgery.

based on a review of about 10,000 patients undergoing cardiac surgery under cpb in west china hospital of sichuan university and the second affiliated hospital of zhejiang university, the following results were obtained: 1. perioperative risk factors of death and complications of different organ systems after cardiac surgery, providing evidence for early prevention and intervention; 2. risk factors of blood transfusion risk were analyzed to provide ideas for reducing intraoperative blood transfusion; 3. the relationship between hemoglobin and complications after heart surgery was explored to provide a factual basis for the development of blood transfusion indications for such patients

Eligibility criteria:
inclusion criteria: * the patients in the west china hospital of sichuan university (july 01, 2011, solstice during june 30, 2017) and the second affiliated hospital of zhejiang university (september 01, 2013, solstice, june 30, 2017) have cardiac surgery under cardiopulmonary bypass (cpb) exclusion criteria: * no
effects of myofascial release and electrical stimulation in chronic pelvic pain

Conditions: Chronic Pelvic Pain; Myofascial Trigger Point Pain

Summary: myofascial pelvic pain (mfpp) caused by myofascial trigger points (mtrps) is a major contributor to chronic pelvic pain in women.in females,pelvic pain is the single most common indication for referral to women's health services.pelvic floor physical therapy with myofascial release improve mobility and reduce pain by releasing the painful trigger points.tools that will be used,for pain numerical pain scale (nps),functional pelvic pain scale(fpps) and pelvic floor impact questionnaire-7 will be used to asses pain and functionality.

myofascial pelvic pain (mfpp) caused by myofascial trigger points (mtrps) is a major contributor to chronic pelvic pain in women. in females, pelvic pain ''is the single most common indication for referral to women's health services. pelvic floor physical therapy with myofascial release improve mobility, and reduce pain by releasing the painful trigger points following restrictions in connective tissues that are related to pelvic floor.in this project we will observe effects of myofascial release with and without electrical stimulation on pain and functionality in women with chronic pelvic pain.it has been hypothesized that myofascial release along with electrical stimulation help in reducing pain and improve functionality in women.patients will be having sessions for consecutive 4 weeks and will be exposed to both types of techniques to find out the effective results. the study will be randomized control trial.for pain numerical pain scale (nps),functional pelvic pain scale(fpps) and pelvic floor impact questionnaire-7 will be used to asses pain and functionality respectively. a randomized control trial will be conducted on two groups. group 1 will receive myofascial release with electrical stimulation in women with chronic pelvic pain for 4 weeks with 50-280 hz frequency and a pulse duration of 50 µs for 10 minutes along with 10 minutes myofascial release..on the other hand group 2 will receive myofascial release without electrical stimulation on pain and functionality in women with chronic pelvic pain. in previous studies there is ample amount of research conducted on chronic pelvic pain but there were very few recent studies available on myofascial release,so this relation of use of myofascial release with and without electrical stimulation on pain and functionality in chronic pelvic pain should also be carried out.

Eligibility criteria:
inclusion criteria: * age 25-40 years, * presence of persistent chronic pelvic pain * \>4 points on a 10 point numeric rating scale for atleast more than 3 months, * atleast 1 active mtrp in one of the muscle groups including the obturator internus, * levator ani,piriformis and coccygeus on pelvic examination. exclusion criteria: * prolapse of the pelvic organ, * pregnency, * fibromyalgia

Keywords: chronic pelvic pain syndrome pelvic floor physical therapy myofascial release myofascial trigger points
prediction of ck-mb release during otherwise successful stenting procedure

Conditions: Diabetes Mellitus

Summary: aims of this study will be to assess the difference in cfv/cfr (coronary flow velocity/reserve) in diabetic vs. non-diabetic patients and to correlate ck-mb, tni and hscrp release after otherwise successful coronary stenting.

post-procedure ck-mb and troponin i (tni) and hscrp elevation, in the absence of obvious procedural events, is most likely caused by distal micro-thromboembolism of platelet aggregates and atheromatous debris causing microvascular bed obstruction. this, in turn, will result in lower coronary flow reserve and regional left ventricular (lv) dysfunction. therefore, patients with normal cfv/cfr (coronary flow velocity/reserve) by doppler wire and ffr (fractional flow reserve) by flow wire should have no peri-procedural ck-mb, tni elevation as compared to patients with peri-procedural ck-mb and tni elevation where all markers of microcirculation will be reduced. this observation will have a prognostic value at short and long-term. this study may also have clinical implications for patients with intra-coronary stenting and normal microvascular parameters post pci that these patients may be discharged early while others may need to be monitored in-hospital for an extended period of time.

Eligibility criteria:
inclusion criteria: * patients \>18 years of age * stable patients who will undergo pci (intent to stent) * patients with de novo type b2/c lesions of native coronary vessels exclusion criteria: * patients with acute myocardial infarction (q wave or non-q wave with ck-mb 5 times above the upper normal \[80 u/l\] within 72 hours) * patients who are in cardiogenic shock * patients with restenotic lesions * patients with type a and type b1 lesions of native coronary vessels * patients who require use of atherectomy devices for pci * patients who have elevated ck-mb (\>16 u/l) or tni (\>2ng/l) at baseline * patients who receive tirofiban or eptifibatide infusion within 24 hours of pci * patients with known allergy to abciximab and adenosine * patients with platelet count \<100,000 cell/mm3 * patients who have co-morbidity which reduces life expectancy to one year * patients who are currently participating in another investigational drug/device study